FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
EAS
Gel, Electrode, For Pulp Tester
1
Product Code
EAT
Tester, Pulp
2
Product Code
EGZ
Holder, Film, X-Ray
1
Product Code
EHA
Aligner, Beam, X-Ray
1
Product Code
JEO
Measurer, Gingival Fluid
1
Product Code
LFC
Device, Caries Detection
2
Product Code
MVH
Device, Detection, Sulfide
2
Product Code
NBL
Laser, Fluorescence Caries Detection
2
Product Code
K
23
1722
SmarTooth
2
Cleared 510(K)
K
22
3470
C50
2
Cleared 510(K)
K
22
1249
L1P-1F (TRIOS 5)
2
Cleared 510(K)
K
18
3471
IC-WHCD100 (Inspire)
2
Cleared 510(K)
K
17
1007
Fluorescence Mode
2
Cleared 510(K)
K
17
0822
Electronic Caries Detector
2
Cleared 510(K)
K
15
0672
VistaCam iX Proof
2
Cleared 510(K)
K
12
1685
SOPROCARE
2
Cleared 510(K)
K
11
2139
THE CANARY SYSTEM
2
Cleared 510(K)
K
11
1423
CS 1600 INTRAORAL CAMERA
2
Cleared 510(K)
Show All 21 Submissions
NFP
Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders
2
Product Code
NFQ
Device, Dental Sonography, For Monitoring Jaw Sounds
1
Product Code
NFR
Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders
2
Product Code
NFS
Device, Jaw Tracking, For Monitoring Jaw Positions
1
Product Code
NTK
Caries Detector, Laser Light, Transmission
2
Product Code
NYH
Plaque Disclosing Kit
2
Product Code
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
DE
/
subpart-b—diagnostic-devices
/
NBL
/
K231722
View Source
SmarTooth
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231722
510(k) Type
Traditional
Applicant
Smartooth Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
5/1/2024
Days to Decision
323 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
EAS
Gel, Electrode, For Pulp Tester
EAT
Tester, Pulp
EGZ
Holder, Film, X-Ray
EHA
Aligner, Beam, X-Ray
JEO
Measurer, Gingival Fluid
LFC
Device, Caries Detection
MVH
Device, Detection, Sulfide
NBL
Laser, Fluorescence Caries Detection
K
23
1722
SmarTooth
K
22
3470
C50
K
22
1249
L1P-1F (TRIOS 5)
K
18
3471
IC-WHCD100 (Inspire)
K
17
1007
Fluorescence Mode
K
17
0822
Electronic Caries Detector
K
15
0672
VistaCam iX Proof
K
12
1685
SOPROCARE
K
11
2139
THE CANARY SYSTEM
K
11
1423
CS 1600 INTRAORAL CAMERA
Show All 21 Submissions
NFP
Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders
NFQ
Device, Dental Sonography, For Monitoring Jaw Sounds
NFR
Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders
NFS
Device, Jaw Tracking, For Monitoring Jaw Positions
NTK
Caries Detector, Laser Light, Transmission
NYH
Plaque Disclosing Kit
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
DE
/
subpart-b—diagnostic-devices
/
NBL
/
K231722
View Source
SmarTooth
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231722
510(k) Type
Traditional
Applicant
Smartooth Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
5/1/2024
Days to Decision
323 days
Submission Type
Summary